Esteem Totally Implantable Hearing System

NCT01092910 | Completed Results DMC

• 1 other identifier: 0204
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.

Conditions

Mild to Severe Sensorineural Hearing Loss

Keywords

Sensorineural; Hearing Loss

Outcome Measures

Primary Outcomes (6)

• SRT Change

  Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

  4 Months Post Activation

• SRT Change

  Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

  10 Months Post-Activation

• Word Recognition Score Change

  Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

  4 Months Post Activation

• Word Recognition Score Change

  Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

  10 Months Post Activation

• SADEs

  The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements

  10 Months Post-Activation

• Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds.

  Comparison of bone conduction thresholds at the 4-month and 10-month post-activation follow-up, relative to the pre-implant baseline bone conduction thresholds. Lower thresholds represent better (more sensitive) outcomes.

  Baseline, 4-, and 10-Months Post-Activation

Secondary Outcomes (4)

• Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score

  4 and 10 Months Post-Activation

• Scores on Esteem Questionnaire

  4 and 10 Months Post Activation

• Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant

  4 Months Post Activation

• Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition

  4 Months Post Activation

Study Arms (1)

Esteem Implant

EXPERIMENTAL

Subjects are implanted with the Esteem Totally Implantable Hearing System

Device: Esteem Totally Implantable Hearing System

Interventions

Esteem Totally Implantable Hearing System DEVICE

The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.

Esteem Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years old
• Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
• Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem System.
• Subject has mild to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow:
• Freq (Hz) 500 1000 2000 3000 4000 LL\* (dB HL) 30 35 35 35 35 UL\* (dB HL) 100 100 100 100 100
• \*LL = Lower Level; UL = Upper Level
• Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz.
• Subject has an unaided maximum word recognition score of greater than or equal to 60% with recorded delivery using a phonetically balanced word list at SRT + 40 dB or at maximum tolerable presentation level.
• Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid.
• Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.
• Subject has normally functioning eustachian tube
• Subject has normal tympanic membrane
• Subject has a normal middle ear anatomy
• Subject has adequate space for Esteem System implant determined via fine cut temporal bone CT scan
• Subject is a native speaker of the English language.

You may not qualify if:

• Subject has a history of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Hydrops or Meniere's syndrome or disease
• Subject has a history of otitis externa or eczema for the outer ear canal and the investigator believes this will affect the Esteem System implantation
• Subject has cholesteatoma or destructive middle ear disease
• Subject has life expectancy of two (2) years due to other medical conditions
• Subject has retrocochlear or central auditory disorders
• Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with the surgery or follow-up testing
• Subject has a known history of fluctuating air conduction and/or bone conduction hearing loss over a one-year period of 15 dB in either direction at 2 or more frequencies (from 500 - 4000 Hz)
• Subject has sudden hearing loss due to unknown cause
• Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
• Subject is unable to adequately perform audiological testing
• Subject has a medical condition or undergoing a treatment that may affect healing and the investigator does not believe the subject is a good candidate for the trial.
• Subject has diabetes that is not well controlled with medication or diet and the investigator does not believe in his best medical judgment that the subject would be a good candidate for the trial
• Subject is pregnant at the time of device implant
• Subject has a history of keloid formation
• Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold

Sponsors & Collaborators

• Envoy Medical Corporation: lead

Study Sites (5)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Shohet Ear Associates

Newport Beach, California, 92663, United States

Location

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Surgical Care Affiliates

Greensboro, North Carolina, 27401, United States

Location

The Ear Center of Greensboro

Greensboro, North Carolina, 27401, United States

Location

Related Links

• Envoy Medical Corporation Official Web Site

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elizabeth Anderson, PhD
• Organization: Envoy Medical Corp.

landerson@envoymedical.com

651-361-8080

Study Officials

• Jack A. Shohet, M.D.

  PRINCIPAL INVESTIGATOR

• Eric M. Kraus, M.D., M.S.

  F.A.C.S.

  PRINCIPAL INVESTIGATOR

• Peter J. Catalano, M.D.

  F.A.C.S.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 25, 2010
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2010
• Last Updated: January 2, 2020
• Results First Posted: February 23, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)